Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00079

2 Trial Registration Date

2005-09-22

i Registration Status

Retrospective

3 Secondary IDs

CUHK4467/04M

4 Source(s) of Funding

1. Research Grants Council, Hong Kong. 2. Departmental funding.

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong

6 Secondary Sponsor

n/a

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Professor W. Ngan Kee

ii Address

iii Phone

warwick@cuhk.edu.hk

iv Email

Email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Professor W. Ngan Kee

ii Address

iii Phone

warwick@cuhk.edu.hk

iv Email

Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

Vasopressor drugs in regional anaesthesia for obstetrics: Quantification of transplacental transfer and determination of metabolic effects on the fetus

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2004-05-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Conditions of the Urinary Tract and Sexual Organs, and Pregnancy

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Vasopressor drugs: ephedrine, phenylephrine

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Approx 30 minutes

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Vasopressor drugs: ephedrine, phenylephrine

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion: term healthy parturients having elective caesarean section under spinal anaesthesia. Exclusion: fetal abnormality, hypertension, preeclampsia

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-01-01

21 Target Sample Size

104

22 Recruitment Status

Recruiting

23 Primary Outcome

Umbilical artery pH

24 Secondary Outcome

Maternal and placental drug levels and biochemical markers.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-10

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-09-22